S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00770120
First received: October 8, 2008
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with pleural malignant mesothelioma that cannot be removed by surgery.


Condition Intervention Phase
Malignant Mesothelioma
Drug: everolimus
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: Every 8 weeks until disease progression ] [ Designated as safety issue: No ]
    Progression-Free Survival was defined as the duration from the date of registration until the date of disease progression per RECIST or death due to any cause. Patients known to be alive without evidence of disease progression were censored at the date of last contact. Disease progression was defined as a >= 20% increase over nadir in the sum of longest diameters of target lesions, unequivocal progression of non-target lesions in the opinion of the treating investigator, appearance of new lesions, symptomatic deterioration, or death due to disease


Secondary Outcome Measures:
  • Response [ Time Frame: Every 8 weeks while on protocol treatment. ] [ Designated as safety issue: No ]
    A response was defined as either a confirmed or unconfirmed complete or partial responses as defined by RECIST. A complete response (CR) was defined as the disappearance of all disease. A partial response (PR) was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was considered confirmed if two consecutive determinations were made at least 4 weeks apart.

  • Overall Survival [ Time Frame: Weekly during the first 8 weeks of treatment, then every 3 weeks while on treatment, then every 8 weeks until disease porgression, then every 6 months thereafter. ] [ Designated as safety issue: No ]
    Overall survival was defined as the duration between the date of enrollment and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.

  • Frequency and severity of toxicities [ Time Frame: From date of registration to 3 years post registration or death (whichever occurs first) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: December 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus
Daily oral Everolimus 10 mg/day
Drug: everolimus

Detailed Description:

OBJECTIVES:

Primary

  • To determine the 4-month progression-free survival in patients with unresectable malignant pleural mesothelioma treated with everolimus.

Secondary

  • To determine the response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate (response or stable disease) in patients with measurable disease by RECIST and modified RECIST criteria.
  • To determine overall survival of these patients.
  • To evaluate the frequency and severity of toxicities associated with this treatment regimen.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant pleural mesothelioma

    • Unresectable disease
  • Must have measurable or nonmeasurable disease by RECIST or modified RECIST criteria
  • Must have received prior systemically administered* platinum-based chemotherapy and meets the following criteria:

    • No more than 2 prior systemic therapeutic regimens allowed (including biologics, targeted, and immunotherapies)
    • At least 1 regimen must have been platinum-based
    • Neoadjuvant and/or adjuvant systemic therapy is not counted as a prior regimen, assuming ≥ 12 weeks have elapsed between the end of neoadjuvant/adjuvant therapy and development of progressive disease NOTE: *Pleural space washing with cisplatin does not constitute systemic administration
  • No known CNS metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Serum bilirubin normal
  • AST or ALT ≤ 1.5 times upper limit of normal (ULN)
  • Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No evidence of bleeding diathesis or coagulopathy

    • Previous pulmonary embolism allowed provided the patient is on therapeutic low molecular weight heparin injections or warfarin AND no evidence of bleeding

      • Patients on therapeutic warfarin must have an INR of < 5 within 28 days prior to registration
  • No pathologic condition other than mesothelioma that carries a high risk of bleeding
  • No known HIV positivity
  • No gastrointestinal tract disease resulting in an inability to take oral or enteral medication via a feeding tube or a requirement for IV alimentation, or active peptic ulcer disease
  • No other prior malignancy allowed except for any of the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • In situ cervical cancer
    • Adequately treated stage I or II cancer from which the patient is currently in complete remission
    • Any other cancer from which patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • At least 28 days since prior systemic therapy (42 days for nitrosoureas or mitomycin C)
  • At least 28 days since prior thoracic or other major surgery (e.g., pleurectomy or pleurodesis) and no anticipated need for major surgical procedures during study
  • At least 14 days since prior radiotherapy
  • No prior surgical procedure affecting absorption
  • No prior chronic, systemic corticosteroids or other immunosuppressive agent, except corticosteroids equivalent to prednisone ≤ 20 mg daily

    • Must have been on a stable dosage regimen for ≥ 4 weeks
    • Topical and inhaled corticosteroids allowed
  • No prior mTOR inhibitor therapy (i.e., rapamycin, everolimus, or temsirolimus)
  • No concurrent immunization with attenuated live vaccines
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational therapy
  • No other concurrent anticancer agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770120

  Show 129 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Sai-Hong I. Ou, MD, PhD Chao Family Comprehensive Cancer Center
Study Chair: Linda Garland, MD University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00770120     History of Changes
Other Study ID Numbers: CDR0000616162, S0722, U10CA032102
Study First Received: October 8, 2008
Last Updated: April 16, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
recurrent malignant mesothelioma
stage II malignant mesothelioma
stage III malignant mesothelioma
stage IV malignant mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 19, 2014